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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04433585




Registration number
NCT04433585
Ethics application status
Date submitted
15/06/2020
Date registered
16/06/2020

Titles & IDs
Public title
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus
Secondary ID [1] 0 0
J1P-MC-KFAJ
Secondary ID [2] 0 0
17422
Universal Trial Number (UTN)
Trial acronym
ISLAND-SLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3471851
Treatment: Drugs - Placebo

Experimental: LY3471851 High Dose - LY3471851 administered subcutaneously (SC).

Experimental: LY3471851 Mid Dose - LY3471851 administered SC.

Experimental: LY3471851 Low Dose - LY3471851 administered SC

Placebo comparator: Placebo - Placebo administered SC.


Treatment: Drugs: LY3471851
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved a =4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851
Timepoint [4] 0 0
Week 24

Eligibility
Key inclusion criteria
* Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
* Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
* Have a positive antinuclear antibody (ANA) (titer =1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
* Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score =6 during screening.
* Have a clinical SLEDAI-2K score =4 at randomization.
* Have active arthritis and/or active rash.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have severe active lupus nephritis.
* Have active central nervous system (CNS) lupus.
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/02/2023
Sample size
Target
Accrual to date
Final
291
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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Massachusetts
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Missouri
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New York
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aire
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Argentina
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Tucumán
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Argentina
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Ciudad Autónoma de Buenos Aire
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Argentina
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Córdoba
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Argentina
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San Juan
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Canada
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Alberta
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Czechia
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Ostrava Mesto
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Czechia
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Praha, Hlavní Mešto
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Germany
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Baden-Württemberg
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Germany
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Nordrhein-Westfalen
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Germany
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North Rhine-Westphalia
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Germany
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Schleswig-Holstein
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Germany
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Kiel
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Germany
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Köln
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Hungary
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Békés
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Hungary
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Budapest
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Hungary
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Debrecen
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India
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Andhra Pradesh
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India
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Delhi
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India
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Gujarat
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India
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Karnataka
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India
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Maharashtra
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Israel
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HaMerkaz
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Tel Aviv
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Japan
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Aichi
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Japan
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Fukuoka
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Hokkaido
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Miyagi
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Nagano
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Japan
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Nagasaki
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Japan
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Chiba
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Korea
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Korea, Republic of
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Seoul, Korea
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Mexico
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Baja California
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Coahuila
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Poland
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Mazowieckie
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Podlaskie
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Bydgoszcz
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Slaskie
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Puerto Rico
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Caguas
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Puerto Rico
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San Juan
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Romania
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Bra?ov
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Romania
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Bucuresti
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Romania
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Galati
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Russian Federation
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Kareliya, Respublika
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Russian Federation
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Moskva
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Russian Federation
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Moscow
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Russian Federation
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Ryazan
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Spain
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Barcelona
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Spain
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Sevilla
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Taiwan
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Kaohsiung City
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Taiwan
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Taichung City
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Taiwan
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Taichung
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Taiwan
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Taipei City
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Odesa
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Ukraine
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Vinnytsya
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Ukraine
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Zaporizhzhia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nektar Therapeutics
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Nektar Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04433585